Kornimate/medical-research-clean huggingface dataset:
evaluation of the rotational stability of the acrysof toric intraocular lens in the capsular bag in high myopic subjects

Conditions: Cataract

Summary: the purpose of this study is to evaluate the stability and efficacy of the acrysof toric intraocular lens in the bag in high myopic subjects.

according to numerous estimations, 15% to 29% of patients with cataract have≥1.5 diopters (d) of refractive astigmatism. new toric iol designs (acrysof © toric iol; alcon), approved by the us food and drug administration (fda) at the end of 2005, have been found to be more stable and safety in the capsular bag in subjects with normal axis length of eye. then,this study aims at the confirmation of the stability of the acrysof toric intraocular lens in the bag in high myopic subjects.then we may find a more effective treatment for the high myopic patients with complicated cataract and sever cornea astigmatism .

Eligibility criteria:
inclusion criteria: 1. sphere more than -6.0d; 2. cornea astigmatism from -1.0 d to -4.0d; 3. clinical diagnosis of complicated cataract; 4. ask for and accept refractive lens exchange surgery; 5. accept acrysof toric intraocular lens . exclusion criteria: 1. other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on; 2. previous corneal or intraocular surgery; 3. refuse surgery; 4. refuse to use acrysof toric intraocular lens .

Keywords: cataract
impact of menstrual cycle on antiretroviral pharmacokinetics in hiv-infected women

Conditions: HIV Infected

Summary: data suggests that women taking drugs to treat human immunodeficiency virus (hiv) have higher amounts of drugs in their body compared with men taking the same dose of anti-hiv drugs. the reason for this higher drug exposure has not yet been determined. the primary purpose of this study is to examine whether a pharmacokinetics (factors that determine the amount of drug in the body) of anti-hiv drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. in other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-hiv drugs in hiv infected women. the antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied.


Eligibility criteria:
inclusion criteria: * hiv positive females between 21-40 years of age. * subjects must be receiving anti-hiv regimen consisting of tenofovir, emtricitabine, atazanavir, and ritonavir for a minimum of 4 weeks prior to the study. * subjects must have regular menstrual cycle (period), define at least 10 cycles a year, occurring approximately every 28 days+/- 4 days and cycle length varying by not more than 7 days. exclusion criteria: * subjects can not be breast feeding, pregnant, or taking oral contraceptives (birth control pills) for at least 3 months prior to the study. * subjects may not have the intrauterine device (iud), mirena, in place to prevent pregnancy.

Keywords: hiv infected women
study of biomarkers in blood and/or tumor tissue samples from patients with ductal carcinoma in situ and from healthy volunteers

Conditions: Breast Cancer

Summary: rationale: studying genes in samples of blood and/or tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. purpose: this research study is looking at blood and/or tumor tissue samples from patients with ductal carcinoma in situ and blood samples from healthy volunteers.

objectives: primary * to collect blood and/or tumor tissue of patients with ductal breast carcinoma in situ (dcis) and their age- and ethnicity-matched controls to identify the inherited variation that predisposes women to develop dcis. * to determine the frequency of these variants. * to determine the effect of these variants on tumor risk. * to determine the benefit of testing for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened. secondary * to analyze the acquired genetic changes within dcis to identify which cases are more likely to develop invasive disease. outline: this is a multicenter study. all participants complete a questionnaire to collect their family history, a brief medical history, and epidemiological data. patients undergo collection of blood and/or tumor tissue samples; dna is extracted for genotyping, comparison of allele and genotype frequencies (polymorphisms), genetic profiling, dna analysis, and protein analysis. histopathology reports are also collected. healthy volunteers undergo collection of blood samples. projected accrual: a minimum of 3,000 patients and 3,000 controls will be accrued for this study.

Eligibility criteria:
disease characteristics: * prior or current diagnosis of pure ductal carcinoma in situ (dcis) * age ≤ 60 years at the time of diagnosis * dcis with contralateral synchronous or asynchronous invasive breast cancer is permitted * dcis associated with microinvasion (foci \< 1 mm) is permitted * healthy age- and ethnicity-matched controls * no history of dcis * no relative (up to second degree) diagnosed with dcis patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: ductal breast carcinoma in situ
oral fluid volume expansion

Conditions: Dehydration; Hydration

Summary: when subjected to fluid loss or fluid deficiency irrespective of disease or environmental factors it is discussed how to rehydrate or how to hydrate prophylactic. in medical care it is common to give infusions. however it has increasingly become common to hydrate the patient through the mouth even early after bowel surgery. moreover it is more simple to provide energy the natural way. which fluid to give, depends on several factors such as possibility to drink, the volume and emptying of the stomach as well as the fluid absorption in the bowel. the provided fluid can also influence this process depending on temperature, osmolality/tonicity and composition (carbohydrates or salts). in this study we wish to study the speed with which the provided fluid is absorbed by the bowels and how fast the fluid is distributed to the different body compartments depending on it's composition. the three fluids will be either tap water, high sodium chloride and a carbohydrate rich fluid.

the healthy volunteer starts the study by voiding. then he/she lies down for 30 minutes. a blood sample is drawn and thereafter the healthy volunteer ingests one of the three fluids. blood samples are drawn 10 times during the following two hours. finally the healthy volunteer is asked to void and the voided urine is measured. the hemoglobin concentrations are used to calculate the blood volume expansion with volume kinetic methods. the process is repeated another two times with the two remaining fluids.

Eligibility criteria:
inclusion criteria: * healthy volunteer * 18 to 50 years old exclusion criteria: * medication * any chronical disease

Keywords: dehydration hydration
virtual care to improve outcomes and recovery from heart failure hospitalization

Conditions: Heart Failure

Summary: the clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. the co-primary clinical outcomes will be obtained at 180 days.

heart failure (hf) is a leading cause of death, hospitalization, and healthcare system expenditure in canada. while care in hf clinics - multidisciplinary clinics that focus on optimal management of hf - improves health outcomes in hf, there are disparities in access to such care across our province. to respond to the needs of patients and the health care system, the investigators propose to develop and implement a virtual model of care that will enable canadians with hf to receive outpatient hf care and medical optimization remotely. the investigators hypothesize that relative to routine care alone, virtual hf clinics will improve a composite of implementation and clinical outcomes. a pilot phase was conducted to assess the acceptability and feasibility of the intervention, assess change in health status, refine the virtual delivery process and healthcare processes, and use these to finalize protocols and guide the larger clinical trial. data collection during the pilot phase focused on the process outcomes approved by hireb (id 5441).

Eligibility criteria:
inclusion criteria: adult patients ≥ 18 years old who: 1. are being discharged after hospitalization or urgent visit for hf as 1. a primary diagnosis or 2. significant complication (prolonging length of stay) of another diagnosis or have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for hf as a primary or secondary diagnosis, as described above. 2. have left ventricular ejection fraction (lvef) \< 50% within the preceding 3 months. 3. have nt-probnp of \> 900 pg/ml during hospital admission or within 7 days after discharge from the ed 4. have a mailing address for patient or caregiver 5. provide verbal consent exclusion criteria: 1. died or left hospital before medically advised hospital discharge 2. unable to self-assess or communicate symptoms (e.g. clinically evident dementia) 3. unable to engage with digital health technology or follow up 4. severe valve disease 5. recipient of or on waiting list for lvad or cardiac transplant 6. complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy 7. severe lung disease with symptoms on minimal exertion, forced expiratory volume during 1 second (fev1) \ 60 mm hg, or on home oxygen 8. severe kidney disease (persistent egfr \< 30 ml/min/1.73m2) 9. active malignancy 10. receiving palliative care or expected life expectancy \< 6 months

Keywords: heart failure randomized controlled trial digital health knowledge translation
adopting a physically active lifestyle through organized walk events among joslin clinic patients

Conditions: Diabetes; Physical Activity

Summary: can participation in group physical activity, such as a community-based organized group walk, help adult diabetes patients develop a physically active lifestyle? can such engagement ultimately lead to an improvement in hemoglobin a1c? to address this question, the investigators have designed this pilot study with the aim to investigate the effect of community-based group walks among joslin adults with diabetes on the development of a physically active lifestyle and glycemic level. the investigators hypothesize that participation in group walking events helps joslin adults with diabetes engage in physical activity and improves glycemic control.


Eligibility criteria:
inclusion criteria: * joslin clinic patients * 18 years or older * a1c between 7.5% - 12.0% * received physician clearance indicating safe to participate in the walk club events * reside within boston and greater boston area * ability to communicate in english and/or chinese * agree to participate in the intervention walk club for 6 consecutive weeks exclusion criteria: * pregnant or breast feeding * unstable angina or myocardial infarction within 1 month prior to screening * unstable gait, severe neuropathy, or deformed foot. * enrolled in another investigational study within 1 month prior to screening for this study * on medications such as prednisone that will affect blood glucose
health-related quality of life for thyroid patients

Conditions: Thyroid Diseases

Summary: background: thyroid diseases are frequent. they include both metabolic changes and gland enlargement (goitre). previous research and clinical suspicion indicate that the life quality of many patients is reduced despite successful treatment. research methods are, however, weak, and a well-tested, disease specific quality of life questionnaire is especially needed. several treatment possibilities exist for each thyroid disease. for example, hypermetabolism can be treated with either medication, radioactive iodine or by surgery. no comparative studies of quality of life using the different treatment modalities exist. purpose: to develop and evaluate a questionnaire to measure health-related quality of life in patients suffering from thyroid diseases. methods: to ensure that all relevant aspects are included, the questionnaire will be developed on the basis of a systematic examination of the scientific literature and interviews with 13 physicians and 100 patients. the questionnaire will then be tested by 100 new patients. after revision, the questionnaire will be answered by 1000 patients with a view to scientifically investigate the measuring capacity of the questionnaire. this will be done using traditional psychology methods (psychometry) as well as modern statistical methods (structural equations for categorical data and "item response" models). relevance: the above-mentioned questionnaire is necessary for clarifying whether these diseases reduce quality of life and, in the long-term, whether a difference in quality of life exists using the different treatment alternatives and whether treatment can be improved. it should also be included in quality protection studies, in the evaluation of new treatment modalities and possibly also in the treatment of the individual patient.


Eligibility criteria:
inclusion criteria: * all patients with benign thyroid disease. exclusion criteria: * unable to complete questionnaire: must be able to read and write danish

Keywords: thyroid disease quality of life patient reported outcome questionnaire quality of life measurement
fluad vs. fluzone high-dose vaccine effectiveness among adults ≥65 years

Conditions: Influenza; Community-acquired Pneumonia; Cardiovascular Events

Summary: this study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aiiv4) versus quadrivalent high-dose inactivated influenza vaccine (hd-iiv4) in preventing polymerase chain reaction (pcr)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24 and 2024/25 influenza seasons. the study is an observational study conducted at kaiser permanente northern california (kpnc), an integrated health care system in the united states.


Eligibility criteria:
inclusion criteria: * age ≥65 years at the time of influenza vaccination * kpnc member at the time of vaccination * receive either aiiv4 or hd-iiv4 at a kpnc facility during the 2023/24 and/or 2024/25 influenza seasons exclusion criteria: * age \<65 years at the time of influenza vaccination * received either aiiv4 or hd-iiv4 in the inpatient setting * receive more than one influenza vaccination during a single season period (i.e., 2023/24 or 2024/25 influenza seasons) * receive an influenza vaccination outside of kpnc
banking of chronic lymphocytic leukemia tumor cells for vaccine generation

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (cll) that is not in clinical remission. this study is a companion study to df/hcc clinical trial 06-196 in which the participants' own cll cells may form part of a vaccine treatment for their leukemia.

* it is important to understand that even if the participant consents to allow us to save their leukemia cells, we cannot guarantee that they will be able to receive a vaccine. first, we may not be able to make enough vaccine from the collected cells. second, they may not be able to participate in a vaccine study in the future for reasons related to the status of your overall health. third, an appropriate vaccine trial may not be available in the future. * in order to make the vaccine, leukemia cells will be collected by one or more of the following methods: drawing blood during one of two visits to the clinic; leukapheresis; bone marrow aspiration; or, surgery to remove a lymph node. * the physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected.

Eligibility criteria:
inclusion criteria: * ability to harvest cll cells from peripheral blood, lymph nodes or bone marrow, defined as \> 30% involvement of bone marrow intratrabecular space, or peripheral blood lymphocytosis \> 5000/microliter, or surgically accessible lymph nodes of greater than or equal to 2cm. * ecog performance status 0-2 * 18 years of age or older exclusion criteria: * uncontrolled infection * leukemia with active cns involvement

Keywords: cll vaccine
efficacy and safety of 1-year duration of dapt after genoss® des implantation in patients with coronary artery disease according to the complex higher-risk procedure

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Dual Antiplatelet Therapy

Summary: the objective of study is to evaluate the efficacy and safety of 1 year duration of dapt after genoss® des implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.

the genoss des is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of 1 year duration of dapt after genoss® des implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure. the genoss des registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of dapt after genoss des implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in south korea. the primary endpoint was a deviceoriented composite endpoint (doce), defined as a composite of cardiac death, target vessel-related myocardial infarction (mi), and clinically indicated target lesion revascularization (tlr) at 12 months. the key secondary endpoint was a patient-oriented composite endpoint (poce), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.

Eligibility criteria:
inclusion criteria: 1. patients of 19 and over 2. patients with coronary artery disease treated with genoss ses 3. participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants exclusion criteria: 1. patients with cardiogenic shock at the time of hospitalization 2. patients who are pregnant or planning to become pregnant 3. patients with a life expectancy of less than 1 year 4. patients participating in randomized controlled trials using other medical devices 5. patients who have already received treatment with another des (drug eluting stent) or bms (bare metal stent) at the time of registration (however, other stent insertions are allowed due to failure of genoss des insertion)
evaluation of the implementation of the hemispheric dominance during development

Conditions: Neuroimaging

Summary: many cognitive functions in human are based on asymmetric brain networks. for most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the right hemisphere. many studies helped to highlight the presence of anatomical and functional asymmetries both in the first months of life. what are the causes of these imbalances? how do they develop? are they necessary for operation or for effective learning? the investigators would like in this work, in collaboration with applied mathematics team of compiègne and inserm team, to determine from which period the development of hemispheric dominance is set up for recognition of language and in which brain structure it occurs in preterm infants whose sound environment is usually very different from that of the fetus. the impact of this environment on brain development of infants and their early learning will be assessed.


Eligibility criteria:
inclusion criteria: * preterm gestational age over 26 weeks of gestation + 6 days and less than 42 weeks. * normal group of children : a child meets the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (etf , scanner, mri). * group of children meet the age criteria and with cerebral neurological pathology detectable after clinical, neurophysiological and radiological (etf , scanner, mri). exclusion criteria: * severe congenital malformation * any refusal of a parent . * children with severe impairment of the general condition and vital functions * children with dermatitis of the face or scalp * children treated with ventilation high frequency (hfo ) * presence of intravenous access on the scalp ( preventing the realization of the etf , eeg or nirs .

Keywords: preterm infants term infants hemispheric dominance
studies of neuregulin/erbb signaling in human heart

Conditions: Heart Disease; Vascular Disease; Heart Failure

Summary: this study examines the role of the epidermal growth factor (egf) receptor family and the egf family of ligands in the regulation of non-myocytes isolated from the human heart.

the egf family of receptor tyrosine kinases (a.k.a. erbb receptors) mediate the effects of the epidermal growth factor (egf) family including neuregulin-1β (nrg). nrg and erbb1-4 are critical for cardiac development and maintenance of the adult heart. current understanding of the role of egf/nrg/erbb signaling in the cardiovascular system is rapidly evolving due to recent findings in non-myocyte cell populations. this study is examining a population of progenitor cells in the adult human heart that responds to egf and nrg. subjects are enrolled who are scheduled to undergo heart surgery and are willing to allow for a small biopsy to be taken from their hearts during surgery. biopsies are taken to the laboratory where cells are separated and analyzed by flow cytometry and grown in cell culture to understand how their biology is regulated by nrg and egf.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of severe coronary artery disease scheduled to undergo coronary artery bypass surgery. exclusion criteria: * less than 18 years of age * unwilling or unable to provide informed consent * known active myocarditis * hypertrophic cardiomyopathy * constrictive pericarditis or other significant pericardial disease * severe pulmonary hypertension * significant renal impairment (cr \> 2.5 mg/dl) * severe ventricular arrhythmias * pregnancy